Resin vs. Amorolfine vs. Terbinafine Treatment in Onychomycosis

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Repolar Ltd.
Information provided by (Responsible Party):
Janne J. Jokinen, Helsinki University Central Hospital
ClinicalTrials.gov Identifier:
NCT01851590
First received: May 8, 2013
Last updated: October 29, 2013
Last verified: October 2013
  Purpose

The aim of this prospective, investistigator-blinded, randomized and controlled clinical trial is to explore potential differences between 5 % amorolfine and 30 % resin lacquer in topical treatment of onychomycosis. In addition, topical treatment methods are compared with the most effective 'drug of choice' for onychomycosis according the current guidelines i.e. oral medication with terbinafine.

Altogether 90 patients (30 patients per group) who have culture or KOH stain verified onychomycosis are randomly allocated into three treatment groups to receive either topical treatment or oral medication for toe- or fingernail onychomycosis classified according to the current guidelines as follows:

  1. White superficial onychomycosis (WSO)
  2. Distal and lateral subungual onychomycosis (DLSO)
  3. Proximal subungual onychomycosis (PSO)
  4. [Total dystrophic onychomycosis) (TDO)] [Excluded]
  5. [Candidal onychomycosis] [Excluded]

Participants are randomized into three groups to receive:

  1. Topical treatment: 30 % resin lacquer (Abicin®)
  2. Topical treatment: 5 % amorolfine lacquer (Loceryl®)
  3. Oral medication: 250 mg terbinafine

All patients visit at outpatient department before the launch of the study, and three and nine months thereafter. Clinical examination is done by four physicians. At every visit, the panel of laboratory tests (S-Krea, S-GT, B-TVK), nail samples for mycological culturing and KOH staining (Sk-SienVi), and digital photographs are taken from the most severely affected onychomycotic nails. At the end of the study, all patients are ordered to discontinue using the resin- or amorolfine lacquer four weeks before the last visit (washout period). During the trial, all participants are contacted at least twice by phone in order to monitor the patient's compliance and willingness to continue in the trial.

In order to control safety and assess potential contraindications for terbinafine, amorolfine or resin, blood samples regarding kidney and liver function are taken in the beginning of the study, as well as at three and nine months, thereafter. The patients' permanent medication is verified against terbinafine, amorolfine and resin in order to exclude potential cross-reactions between the patient's permanent medication and current antifungal treatment. Sensitivity or allergy for terbinafine, amorolfine or resin is taken into account, and if any symptoms of allergic reactions appear, the study is discontinued for this particular patient.


Condition Intervention
Onychomycosis
Drug: Amorolfine
Drug: Terbinafine
Device: Resin lacquer

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: The Efficacy of Resin Lacquer vs. Amorolfine vs. Terbinafine in Treatment of Onychomycosis: Prospective, Investigator-blinded, Randomized and Controlled Clinical Trial

Resource links provided by NLM:


Further study details as provided by Helsinki University Central Hospital:

Primary Outcome Measures:
  • Mycological cure [ Time Frame: At 6- and 9 months time-points from the beginning of antifungal treatment ] [ Designated as safety issue: No ]
    To analyze the rate of mycological cure i.e. fungal eradication in terms of mycological culture and potassium hydroxide (KOH) stain during the treatment period.


Secondary Outcome Measures:
  • Clinical cure [ Time Frame: At 6- and 9 months time-points from the beginning of antifungal treatment ] [ Designated as safety issue: No ]
    To assess objective and subjective clinical treatment result according to the clinical classification of onychomycosis.


Other Outcome Measures:
  • Costs [ Time Frame: At 9 months time-point from the beginning of antifungal treatment ] [ Designated as safety issue: No ]
    To assess and compare the total costs of topical and oral treatment.


Estimated Enrollment: 90
Study Start Date: October 2013
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Amorolfine
Topical treatment with 5 % amorolfine lacquer (Loceryl)
Drug: Amorolfine
Amorolfine is administered locally in the form of lacquer (Loceryl®) onto infected nail once a week for nine months in toenail onychomycosis and six months in fingernail onychomycosis.
Active Comparator: Terbinafine
Oral medication with 250 mg terbinafine / day
Drug: Terbinafine
Terbinafine 250 mg is administered orally once a day for three months in toenail onychomycosis and six weeks in fingernail onychomycosis.
Active Comparator: Resin lacquer
Topical treatment: 30 % resin lacquer (Abicin)
Device: Resin lacquer
Resin is administered locally in the form of lacquer (Abicin®) onto infected nail once a day for nine months in toenail onychomycosis and six months in fingernail onychomycosis.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

-positive dermatophyte culture or KOH stain in the beginning of the study obtained from the finger- or toenail sample.

Exclusion Criteria:

  • any other nail disease than dermatophyte culture or KOH stain verified onychomycosis
  • Onychomycosis caused by yeasts or nondermatophyte molds
  • Kidney failure determined by serum creatinine level (S-Krea > 100 μmol/l)
  • Liver failure determined by serum glutamyltransferase (GT) level (S-GT > 105 U/I)
  • sensitivity or allergy to resin, amorolfine or terbinafine
  • Potential adverse cross-reaction of terbinafine, amorolfine or resin with the patient's permanent medication
  • Presence of total dystrophic onychomycosis (TDO)
  • Any topical or oral antifungal treatment within the six months before the beginning of the study (washout period > 6 months).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01851590

Locations
Finland
Vääksyn Lääkärikeskus
Vääksy, Finland, FI-17200
Sponsors and Collaborators
Helsinki University Central Hospital
Repolar Ltd.
Investigators
Principal Investigator: Janne J. Jokinen, MD, PhD Dept. of Cardiothoracic Surgery, Helsinki University Hospital, Haartmaninkatu 4, PO Box 340, FI-00029 Helsinki, Finland
  More Information

No publications provided

Responsible Party: Janne J. Jokinen, Consult in Cardiothoracic Surgery, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT01851590     History of Changes
Other Study ID Numbers: 334/13/03/01/2012, 2012-004822-48
Study First Received: May 8, 2013
Last Updated: October 29, 2013
Health Authority: Finland: Ethics Committee

Keywords provided by Helsinki University Central Hospital:
Onychomycosis
Fungal nail infection
Resin Lacquer
Amorolfine
Terbinafine

Additional relevant MeSH terms:
Onychomycosis
Tinea
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Nail Diseases
Skin Diseases
Amorolfine
Terbinafine
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014